Design and rationale of the Post-Intensive Care Syndrome – paediatrics (PICS-p) Longitudinal Cohort Study

Introduction As paediatric intensive care unit (PICU) mortality declines, there is growing recognition of the morbidity experienced by children surviving critical illness and their families. A comprehensive understanding of the adverse physical, cognitive, emotional and social sequelae common to PIC...

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Main Authors: David Wypij, Gillian Colville, Joseph C Manning, Martha A Q Curley, R Scott Watson, Elizabeth Y Killien, Laura Beth Kalvas, Mallory A Perry-Eaddy, Amy M Cassidy, Erica B Miller, Mritika Talukder, Neethi P Pinto, Janet E Rennick, Lisa A Asaro
Format: Article
Language:English
Published: BMJ Publishing Group 2024-02-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/14/2/e084445.full
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author David Wypij
Gillian Colville
Joseph C Manning
Martha A Q Curley
R Scott Watson
Elizabeth Y Killien
Laura Beth Kalvas
Mallory A Perry-Eaddy
Amy M Cassidy
Erica B Miller
Mritika Talukder
Neethi P Pinto
Janet E Rennick
Lisa A Asaro
author_facet David Wypij
Gillian Colville
Joseph C Manning
Martha A Q Curley
R Scott Watson
Elizabeth Y Killien
Laura Beth Kalvas
Mallory A Perry-Eaddy
Amy M Cassidy
Erica B Miller
Mritika Talukder
Neethi P Pinto
Janet E Rennick
Lisa A Asaro
author_sort David Wypij
collection DOAJ
description Introduction As paediatric intensive care unit (PICU) mortality declines, there is growing recognition of the morbidity experienced by children surviving critical illness and their families. A comprehensive understanding of the adverse physical, cognitive, emotional and social sequelae common to PICU survivors is limited, however, and the trajectory of recovery and risk factors for morbidity remain unknown.Methods and analysis The Post-Intensive Care Syndrome – paediatrics Longitudinal Cohort Study will evaluate child and family outcomes over 2 years following PICU discharge and identify child and clinical factors associated with impaired outcomes. We will enrol 750 children from 30 US PICUs during their first PICU hospitalisation, including 500 case participants experiencing ≥3 days of intensive care that include critical care therapies (eg, mechanical ventilation, vasoactive infusions) and 250 age-matched, sex-matched and medical complexity-matched control participants experiencing a single night in the PICU with no intensive care therapies. Children, parents and siblings will complete surveys about health-related quality of life, physical function, cognitive status, emotional health and peer and family relationships at multiple time points from baseline recall through 2 years post-PICU discharge. We will compare outcomes and recovery trajectories of case participants to control participants, identify risk factors associated with poor outcomes and determine the emotional and social health consequences of paediatric critical illness on parents and siblings.Ethics and dissemination This study has received ethical approval from the University of Pennsylvania Institutional Review Board (protocol #843844). Our overall objective is to characterise the ongoing impact of paediatric critical illness to guide development of interventions that optimise outcomes among children surviving critical illness and their families. Findings will be presented at key disciplinary meetings and in peer-reviewed publications at fixed data points. Published manuscripts will be added to our public study website to ensure findings are available to families, clinicians and researchers.Trials registration number NCT04967365.
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spelling doaj.art-4ddb82bf88924d608ead0a64abbaea682024-08-13T01:55:10ZengBMJ Publishing GroupBMJ Open2044-60552024-02-0114210.1136/bmjopen-2024-084445Design and rationale of the Post-Intensive Care Syndrome – paediatrics (PICS-p) Longitudinal Cohort StudyDavid Wypij0Gillian Colville1Joseph C Manning2Martha A Q Curley3R Scott Watson4Elizabeth Y Killien5Laura Beth Kalvas6Mallory A Perry-Eaddy7Amy M Cassidy8Erica B Miller9Mritika Talukder10Neethi P Pinto11Janet E Rennick12Lisa A Asaro13Harvard T.H. Chan School of Public Health, Harvard University, Boston, Massachusetts, USASt George`s University of London, London, UKSchool of Healthcare, University of Leicester, Leicester, UKSchool of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USAUniversity of Washington School of Medicine, Seattle, Washington, USASeattle Children`s Research Institute, Seattle, Washington, USASchool of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USASchool of Nursing, University of Connecticut, Storrs, Connecticut, USASchool of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USASeattle Children`s Research Institute, Seattle, Washington, USASchool of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USAThe Children`s Hospital of Philadelphia, Philadelphia, Pennsylvania, USAMcGill University Health Centre, Montreal Children`s Hospital, Montreal, Québec, CanadaBoston Children`s Hospital, Boston, Massachusetts, USAIntroduction As paediatric intensive care unit (PICU) mortality declines, there is growing recognition of the morbidity experienced by children surviving critical illness and their families. A comprehensive understanding of the adverse physical, cognitive, emotional and social sequelae common to PICU survivors is limited, however, and the trajectory of recovery and risk factors for morbidity remain unknown.Methods and analysis The Post-Intensive Care Syndrome – paediatrics Longitudinal Cohort Study will evaluate child and family outcomes over 2 years following PICU discharge and identify child and clinical factors associated with impaired outcomes. We will enrol 750 children from 30 US PICUs during their first PICU hospitalisation, including 500 case participants experiencing ≥3 days of intensive care that include critical care therapies (eg, mechanical ventilation, vasoactive infusions) and 250 age-matched, sex-matched and medical complexity-matched control participants experiencing a single night in the PICU with no intensive care therapies. Children, parents and siblings will complete surveys about health-related quality of life, physical function, cognitive status, emotional health and peer and family relationships at multiple time points from baseline recall through 2 years post-PICU discharge. We will compare outcomes and recovery trajectories of case participants to control participants, identify risk factors associated with poor outcomes and determine the emotional and social health consequences of paediatric critical illness on parents and siblings.Ethics and dissemination This study has received ethical approval from the University of Pennsylvania Institutional Review Board (protocol #843844). Our overall objective is to characterise the ongoing impact of paediatric critical illness to guide development of interventions that optimise outcomes among children surviving critical illness and their families. Findings will be presented at key disciplinary meetings and in peer-reviewed publications at fixed data points. Published manuscripts will be added to our public study website to ensure findings are available to families, clinicians and researchers.Trials registration number NCT04967365.https://bmjopen.bmj.com/content/14/2/e084445.full
spellingShingle David Wypij
Gillian Colville
Joseph C Manning
Martha A Q Curley
R Scott Watson
Elizabeth Y Killien
Laura Beth Kalvas
Mallory A Perry-Eaddy
Amy M Cassidy
Erica B Miller
Mritika Talukder
Neethi P Pinto
Janet E Rennick
Lisa A Asaro
Design and rationale of the Post-Intensive Care Syndrome – paediatrics (PICS-p) Longitudinal Cohort Study
BMJ Open
title Design and rationale of the Post-Intensive Care Syndrome – paediatrics (PICS-p) Longitudinal Cohort Study
title_full Design and rationale of the Post-Intensive Care Syndrome – paediatrics (PICS-p) Longitudinal Cohort Study
title_fullStr Design and rationale of the Post-Intensive Care Syndrome – paediatrics (PICS-p) Longitudinal Cohort Study
title_full_unstemmed Design and rationale of the Post-Intensive Care Syndrome – paediatrics (PICS-p) Longitudinal Cohort Study
title_short Design and rationale of the Post-Intensive Care Syndrome – paediatrics (PICS-p) Longitudinal Cohort Study
title_sort design and rationale of the post intensive care syndrome paediatrics pics p longitudinal cohort study
url https://bmjopen.bmj.com/content/14/2/e084445.full
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